作者: Izet M. Kapetanovic , Alexander V. Lyubimov
DOI: 10.1002/9780470249031.CH5
关键词:
摘要: Analytical methodology plays an integral part of drug development from the initial synthesis and manufacture through clinical trials postmarketing monitoring. Selection analytical chemical method to be used should based on nature analyte(s), goals (sensitivity, selectivity, etc.), sample matrix, stability. This article focuses validation methods. Keywords: analytical methodology; validation; sampling; sample preparation